Chewable product including active ingredient

ABSTRACT

Products and methods of delivering medicaments are provided. The product includes a chewing gum center including a compressible powder that is compressed around the center. The powder includes a medicament that may or may not be encapsulated.

BACKGROUND OF THE INVENTION

The present invention generally relates to the delivery of medicamentsand agents. More specifically, the present invention relates to thedelivery of medicaments and agents using products including chewing gum.

It is of course known to provide agents to individuals for a variety ofpurposes. These agents can be used to treat diseases and as such aretypically referred to as drugs or medicaments. Likewise, the drugs ormedicaments can be used for prophylactic purposes. Still, it is known toprovide agents to an individual for a variety of nonmedical purposesincluding enhancing performance or maintaining or initiating alertness.

There are a great variety of such agents. These agents run the gamutfrom stimulants such as caffeine to drugs such as analgesics,tranquilizers, cardiovascular products, insulin, etc. Some such agentsare taken on an as needed basis while other agents must be taken atregular intervals by the individual.

Typically, drugs (medicaments) are administered parenterally orenterally. Of course, parenteral administration is the administration ofthe drug intravenously directly into the blood stream. Enteral refers tothe administration of the drug into the gastrointestinal tract. Ineither case, the goal of the drug administration is to move the drugfrom the site of administration towards the systemic circulation.

Except when given intravenously, a drug must traverse severalsemipermeable cell membranes before reaching general circulation. Thesemembranes act as a biological barrier that inhibits the passage of drugmolecules. There are believed to be four processes by which drugs moveacross a biological barrier: passive diffusion; facilitated diffusion;active transport; and pinocytosis.

Passive diffusion is the transport across the cell membrane wherein thedriving force for the movement is the concentration gradient of thesolute. In orally administered drugs, this absorption occurs in thesmall intestines. Facilitated diffusion is believed to be based on acarrier component that combines reversibly with the substrate moleculeat the cell membrane exterior. The carrier substrate complex diffusesrapidly across the membrane with release of the substrate at theinterior surface. Active transport requires an energy expenditure by thecell and appears to be limited to agents with structural similarities tonormal body constituents. These agents are usually absorbed fromspecific sites in the small intestines. Pinocytosis refers to theengulfing of particulars or fluid by a cell. It is believed to play aminor role in drug transport. Merck Manual, 16th Edition, pp. 2598-2599.

In determining the efficacy of a drug and the effectiveness of the useof a drug to treat a disease, drug absorption is a critical concern.Drug absorption refers to the process of drug movement from the site ofadministration toward the systemic circulation.

Oral administration of drugs is by far the most common method. Whenadministered orally, drug absorption usually occurs due to the transportof cells across the membranes of the epithelial cells within thegastrointestinal tract. Absorption after oral administration isconfounded by numerous factors. These factors include differences downthe alimentary canal in: the luminal pH; surface area per luminalvolume; perfusion of tissue, bile, and mucus flow; and the epithelialmembranes. See Merck Manual page 2599.

A further issue effecting the absorption of orally administered drugs isthe form of the drug. Most orally administered drugs are in the form oftablets or capsules. This is primarily for convenience, economy,stability, and patient acceptance. Accordingly, these capsules ortablets must be disintegrated or dissolved in the stomach beforeabsorption can occur. There are a variety of factors capable of varyingor retarding disintegration of solid dosage forms. Further, there are avariety of factors that effect the dissolution rate and thereforedetermine the availability of the drug for absorption. See Merck Manualat page 2600.

Parenteral administration allows for the direct placement of the druginto the blood stream. This usually ensures complete delivery of thedose to the general circulation. However, administration by a route thatrequires drug transfer through one or more biologic membranes to reachthe blood stream precludes a guarantee that all of the drug willeventually be absorbed. Even with parental administration, becausecapillaries tend to be highly porous, the perfusion (blood flow/gram oftissue) is a major factor in the rate of absorption. Thus, the injectionsite can markedly influence a drugs' absorption rate; e.g., theabsorption rate of diazepam injected IM into a site with poor blood flowcan be much slower than following an oral dose. See Merck Manual at page2601.

Not only is drug absorption an issue in drug delivery but, thebioavailability of the drug is also critical. Bioavailability is definedas the rate at which and the extent to which the active moiety (drug ormetabolite) enters the general circulation, thereby gaining access tothe site of action. Bioavailability depends upon a number of factors,including how a drug product is designed and manufactured, itsphysicochemical properties, and factors that relate to the physiologyand pathology of the patient. See Merck Manual at page 2602.

When a drug rapidly dissolves from a drug product and readily passesacross membranes, absorption from most site administration tends to becomplete. This is not always the case for drugs given orally. Beforereaching the vena cava, the drug must move down the alimentary canal andpass through the gut wall and liver, which are common sites of drugmetabolism. Thus, the drug may be metabolized before it can be measuredin the general circulation. This cause of a decrease in drug input iscalled the first pass effect. A large number of drugs show lowbioavailability owing to an extensive first pass metabolism. The twoother most frequent causes of low bioavailability are insufficient timein the GI tract and the presence of competing reactions. See MerckManual at page 2602.

Bioavailability considerations are most often encountered for orallyadministered drugs. Differences in bioavailability can have profoundclinical significance.

Although parenteral administration does provide a method for eliminatinga number of the variables that are present with oral administration,parenteral administration is not a preferable route. Typically,parenteral administration requires the use of medical personnel and isjust not warranted nor practical for the administration of most agentsand drugs, e.g., analgesics. Even when required parenteraladministration is not preferred due to patient concerns includingcomfort, infection, etc., as well as the equipment and costs involved.However, despite best efforts certain therapies require parenterallyinjected drugs. For example, research for decades has focused on anattempt to deliver insulin to an individual through a non-parentalmeans. Despite such efforts today insulin is still only administeredintravenously.

There is therefore a need for an improved method of delivering drugs andagents to an individual.

SUMMARY OF THE INVENTION

The present invention provides improved products and methods fordelivering a medicament or agent to an individual. Improved formulationsincluding medicaments or agents are also provided by the presentinvention.

To this end, the present invention provides a chewing gum productincluding a medicament comprising a chewing gum center and acompressible composition including a medicament, that may beencapsulated, that is compressed around the chewing gum center.

In an embodiment, the product has a disk shape.

In an embodiment, the product has a pellet shape.

In an embodiment, the product has a spherical shape.

In an embodiment, the product has a cube shape.

In an embodiment, the encapsulated medicament is encapsulated with acomposition selected from the group consisting of: natural polymers;synthetic polymers; modified cellulosics; and protein.

In an embodiment, the chewing gum center has the same shape as theproduct.

In an embodiment, the medicament is selected from the group consistingof: analgesics; muscle relaxants; antacids; antihistamines;decongestants; anti-inflammatories; antibiotics; anti-virals;psycotherapeutic agents; hormones; cardiovascular agents; vitamins;minerals; and nutriceuticals.

In an embodiment, the compressible composition includes a masking agent.

In another embodiment of the present invention, a composition includinga medicament is provided comprising a chewing gum center and acompressible formulation including a medicament that surrounds theentire chewing gum center.

In an embodiment, the medicament is encapsulated.

In an embodiment, the medicament is encapsulated with a compositionselected from the group consisting of: natural polymers; syntheticpolymers; modified cellulosics; and protein.

In an embodiment, the medicament is selected from the group consistingof: analgesics; muscle relaxants; antacids; antihistamines;decongestants; anti-inflammatories; antibiotics; anti-virals;psycotherapeutic agents; hormones; cardiovascular agents; vitamins;minerals; and nutriceuticals.

In a further embodiment of the present invention, an acetominophencontaining product is provided comprising a chewing gum center and acompressible composition including encapsulated acetaminophen that iscompressed around the chewing gum center.

In yet another embodiment of the present invention a method ofdelivering a medicament is provided comprising the steps of: providing achewing gum center; compressing around the chewing gum center acomposition including a medicament; and causing an individual in need ofthe medicament to chew the product.

In an embodiment, the medicament is encapsulated.

In an embodiment, the medicament is selected from the group consistingof: analgesics; muscle relaxants; antacids; antihistamines;decongestants; anti-inflammatories; antibiotics; anti-virals;psycotherapeutic agents; hormones; cardiovascular agents; vitamins;minerals; and nutriceuticals.

Still further, in an embodiment, the present invention provides a methodfor providing a medicament comprising the steps of: providing a chewinggum center; and compressing around the chewing gum center a compositionincluding a medicament.

Additionally, the present invention provides a method of producing amedicament containing product comprising the steps of: producing achewing gum center; and surrounding the chewing gum center with a powderthat includes a medicament.

Accordingly, an advantage of the present invention is to provide newmethods for delivering medicaments to an individual.

Furthermore, an advantage of the present invention is to provideimproved products containing a medicament.

Still further, an advantage of the present invention is to provide amethod of delivering medicaments to an individual that provides forincrease absorption and bioavailability as compared to medicaments thatare designed to be absorbed in the GI tract.

Another advantage of the present invention is to provide a novel methodof delivering medicaments to an individual that provide relief from painsymptoms.

Further, an advantage of the present invention is to provide chewing gumproducts containing medicaments that have excellent content uniformity.

Still, an advantage of the present invention is to provide a method ofdelivering medicaments that does not require the individual to takewater.

Moreover, an advantage of the present invention is to provide a methodfor administering medicaments to an individual that heretofore wereadministered parentally.

Additionally, an advantage of the present invention is to provide amethod for administering medicaments that is more palatable than currentmethods.

Another advantage of the present invention is to provide an improvedmethod for drug delivery.

An additional advantage of the present invention is that it can providean acetaminophen containing product that can be chewed and is palatable.

Further, an advantage of the present invention is that a chewing gumproduct including medicament is provided that can have a variety ofshapes.

Additional features and advantages of the present invention will bedescribed in and apparent from the detailed description of the inventionand the figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates generally an embodiment of the product of the presentinvention.

FIG. 2 illustrates graphically the results of Experiment No. 1 that isdiscussed supra.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides improved methods for deliveringmedicaments and other agents to an individual as well as improvedproducts including such medicaments or agents.

Pursuant to the present invention, a medicament is contained in acompressible formulation that surrounds a gum center. As the chewing gumis chewed, the medicament is released into the saliva. During continualchewing, the medicament in the saliva is then forced through the oralmucosa in the buccal cavity due to the pressure created by the chewing.The oral mucosa has a thin epithelium and a rich vascularity. Thus, theoral mucosa favors drug absorption. In contrast to a typically orallyingested drug, wherein the solution is in contact too briefly forabsorption to be appreciable through the oral mucosa, it is believedthat during chewing, the agent and/or medicament remains in the buccalcavity and is forced through the oral mucosa. Also it has beensurprisingly found that an increase in the absorption of the drug isachieved as well as an increase in the bioavailability of the drug ascompared to typical oral administration. It has been found that themedicament is absorbed much quicker than if it was swallowed as in atypical oral administration. Indeed, the absorption may in certain casesapproach that of a parenteral administration, and the bioavailability ismuch greater than oral administration.

Referring to FIG. 1, an embodiment of the product 10 of the presentinvention is illustrated. As illustrated, the product 10 includes a gumcenter 12. The gum center 12 can be any chewing gum formulation known inthe art. Pursuant to the present invention, surrounding the gum center12 is a compressed powder 14. The compressed powder 14 is a compressibleformulation that is compressed around the chewing gum center 12, andincludes a medicament or other active agent. It should be noted, ifdesired, the gum center can also include medicaments.

By using a compressible formulation including a medicament, a variety ofshapes and products can be provided. In the preferred embodimentillustrated in FIG. 1, a disk shaped product 10 is provided. However,any geometry can be created, including cubes, pellets, ovals, andspheres. Further, if desired, indicia can be stamped onto the compressedpowder 14 and thereby the product 10.

It should be noted that the gum center 12 can either be completelyencased by the compressed powder 14 or it may be partially exposed.Further, the gum center 12 may either have the same shape as thecompressed powder 14 and the product 10 or it can have a differentshape. For example, a spherical gum center can be utilized with an ovalcompressed product.

Pursuant to the present invention, a compressible formulation, powder,is compressed around the chewing gum center in order to form theproduct. This provides advantages over creating chewing gum productsthat may be coated with a medicament. In this regard, typically chewinggum coatings are created by a pan coating process. The present inventionprovides a number of advantages over the pan coating processes. Pancoating processes typically allow for less than 200 mg/piece of theactive agent. There can also be processing control and dosing issueswith respect to products produced using current pan coating processes.Further, pan coated procedures may create stability and shelf lifeissues with respect to the resultant product.

By utilizing a compressible powder for creating a tableted product,excellent content uniformity can be provided. For example, in anembodiment, it has been found that a product can be provided that willhave ±3.1% at 300 mg dosage which is ±10.9 mgs.

As noted above, the compressible powder includes a medicament. Themedicament can be blended with a powder to create the compressed powderthrough a variety of methods. The blending may be performed by astandard mixing means, using a Vee Blender, a Ribbon Blender or othermixer. The powder is formulated to provide a compressible matrix, usingbulk fillers, sorbitols, sugars, polyols, starches, sugars modified withstarches and the like. Preferably, this filler can range fromapproximately 10 to about 95% by weight composition of the powder andactive/medicament blend. Preferably the active/medicament may range fromapproximately 0.001 to about 60% by weight of the powder andactive/medicament blend. Other components that can be present in thepowder include flavors, colors, sweeteners and high potency sweeteners.Other excipients can also be used in the powder that are useful inmodifying mouthfeel and organoleptic properties of the product.Excipients may also be used to modify dissolution and disintegrationproperties and binding of the product. Preferably the weight of thepowder and active/medicament blend may range from approximately 10 toabout 90% weight of the total product.

As noted above, if desired, the medicament can be encapsulated or it canbe free. In order to produce the encapsulated medicament, a variety oftechnologies can be utilized. For example, film coating technologies canbe used to provide effective taste masking of a pharmaceutical agent. Anumber of materials can be utilized to encapsulate the medicamentincluding, natural polymers, synthetic polymers, modified cellulose,waxes, fats, oils, and proteins. In addition, a diverse range ofmodifiers can be used, including, but not limited to, plasticizers, poreformers, disintegrants, waxes, lipids, fats, fatty acids, polylactides,solubilizers, and absorption enhancers.

Several encapsulating techniques can be used to encapsulate themedicament. These include fluid-bed coating and its variations,low-shear wet granulations, high-shear wet granulations, and spray dryprocesses. The encapsulations provide for coated solid particles andmatrix dispersions. This enhances bioavailability, taste masking, andtailored release profiles. It has been found that high-sheargranulations of active powder with modifying agents provide for tastemasking, absorption enhancement, dissolution aides, and mouth feelmodifiers. The tailored release profile focuses on the immediate releaseof a pharmaceutical/active, a standard delivery profile of pill forms ofmedicaments/actives and delayed or sustained release of a pharmaceuticalactive as given by entreric coating processes.

The compressed powder can include masking agents. In this regard,high-intensity sweeteners and appropriate flavors can be used to maskany off notes that are present due to the medicament or agent. It hasbeen found that with respect to certain medicaments or agents that mayhave an astringent or bitter taste that by adding a masking agent to theformulation, that a much more palatable formulation, including themedicament, can be provided.

The masking agents, in an embodiment, are selected from the groupconsisting of sucralose; zinc gluconate; ethyl maltol; glycine;acesulfame-k; aspartame; saccharin; fructose; xylitol; maltitol; coolingagents; isomalt; salt; spray dried licorice root; glycyrrhizin;dextrose; sodium gluconate; sucrose; glucono delta-lactone; ethylvanillin; and vanillin.

In an embodiment of the invention, sufficient masking agent will be usedin the compressed powder to improve and provide acceptable organolepticproperties to the chewing gum product. As used herein to provide“acceptable organoleptic properties” means that the product will have asufficiently pleasant, or at least non-offensive taste, to allow theconsumer to chew the chewing gum for at least two minutes. Whether amasking agent is necessary and/or the amount of masking agent will varydepending on medicament. Of course, if desired, more than one maskingagent can be used, e.g., zinc gluconate and a sweetener or flavor. In anembodiment, the masking agent may comprise approximately 10% to about90% by weight of the powder formulation.

In a preferred embodiment, the compressed powder includes ahigh-intensity sweetener such as aspartame, sucralose, and acesulfame-k.In an embodiment, the high-intensity sweetener comprises approximately0.5% to about 5% by weight of the coating.

The core, center of the product is chewing gum. It has been found thatthis component of the present invention reduces any aftertaste that maybe present from the medicament. The gum also speeds delivery of the drugby increasing production of saliva. The increase in saliva assists inswallowing the medicament without drinking water. Further an increasedabsorption is achieved through oral mucosa by creating fluid pressure.

Standard gum formulas known in the art can be used for the chewing gumcore center of the product. The chewing gum will be formulated in size,mass and texture to minimize chew-in activity of medicament into thecud. This can be accomplished by increasing the amount of base andfiller in the chewing gum. The amount of gum will be enough to provide areasonable cud size, e.g., in a range of 0.1 grams to 3 grams.

The compression of the powder and medicament blend around the chewinggum center can be performed by modifying existing tableting equipmentpresently used in the pharmaceutical industry. For example, amodification can be made to equipment as the Single Layer or MultilayerRotary Tablet Press, to include placement of a core, prior to finalcompression. The powder blend will then surround the gum core center andis mechanically compressed to form the final product.

It has also been surprisingly found that by placing a medicament in anpowder that is compressed around a gum center less medicament or agentcan be placed in the product than is typically orally administered to anindividual to achieve an effect and the same bioequivalence can beachieved. In fact, it has been surprisingly found that in certaininstances, for at least certain drugs and agents, the administration ofthe medicament or agent using chewing gum through the buccal cavity canprovide an increase effect even as compared to parenteraladministration.

It is envisioned, that a variety of different medicaments and agents canbe placed in the compressed powder. Generally, such medicaments include,inter alia, analgesics, antibiotics, antivirals, antihistamines,anti-inflammatories, cancer chemotherapies, antimycotics, oralcontraceptives, diuretics, antitussives, anesthetics, nutraceuticals,bioengineered pharmaceuticals, oral vaccines, probiotics, decongestants,antacids, muscle relaxants, psychotherapeutic agents, hormones, insulin,vitamins, and minerals and cardiovascular agents. For example, suchagents include, inter alia, stimulants such as caffeine. It isenvisioned, that depending on the medicament, the resultant chewing gumcan be used to treat, inter alia: coughs; colds; motion sickness;allergies; fevers; pain; inflammation; sore throats; cold sores; sinusproblems; diarrhea; diabetics; depression; anxiety; and other maladiesand symptoms. Specific agents/medicaments include, by way of example andnot limitation: caffeine; aspirin; acetaminophen; ibuprofen;hydroxycitric acid; antacids; chromium picolinate; phosphatidylserine;nicotine (for smoking cessation); insulin; Echinacea purpurea; zinc;vitamin C; ginseng; kola nut; kaua kaua; and chamomile.

In an embodiment, the medicaments are contained in the compressed powdercoating of the chewing gum formulation at levels of approximately 50micrograms to 500 milligrams. The specific levels will depend on theactive ingredient. The level of medicament or agent in the compressedpowder of the chewing gum formulation is selected so as to create, whenthe product is chewed, a sufficiently high concentration of themedicament or agent in the saliva.

In an embodiment of the present invention, the product includesencapsulated acetaminophen. Preferably the product includes at least 250mg of acetaminophen and in an embodiment 500 mg. It has been found thatthe acetaminophen is quickly released from the product into the salivaof the individual chewing the product.

Pursuant to the present invention, depending on the medicament, thedosing regiment will change. For example, if the medicament is ananalgesic, the chewing gum would be taken on an as needed basis. Ofcourse, similar to the oral administration of an analgesic, there wouldbe restrictions on the number of pieces of chewing gum, chewed, forexample, not more often than one stick every four hours and not moreoften than four to five times a day.

The powder including medicament can surround a variety of different gumcenter compositions. Referring now to the chewing gum center, pursuantto the present invention, the gum center may be based on a variety ofdifferent chewing gums that are known. For example, the gum center canbe low or high moisture, sugar or sugarless, wax containing or wax free,low calorie (via high base or low calorie bulking agents), and/or maycontain dental agents.

Chewing gum generally consists of a water insoluble gum base, a watersoluble portion, and flavor. The water soluble portion dissipates with aportion of the flavor of the gum over a period of time during chewing.The gum base portion is retained in the mouth throughout the chew.

The insoluble gum base generally comprises elastomers, resins, fats andoils, softeners and inorganic fillers. The gum base may or may notinclude wax. Typically, gum base comprises approximately 20 to about 40%of the gum product. However, because in the present invention such ahigh level of coating is used, the gum center is unusually small;otherwise the entire coating chewing gum piece would be too large forconsumption. If atypical amount of gum base was used in the small gumcenter, it would result in an inadequate cud to masticate. Consequently,in the present invention, the base level is higher than normal. Theinsoluble gum base can constitute approximately 30% to about 90% byweight of the chewing gum, in an embodiment, the gum base comprises atleast 50% of the chewing gum.

In an embodiment, the chewing gum base of the present invention containsabout 20% to about 60% by weight synthetic elastomer, about 0% to about30% by weight natural elastomer, about 5% to about 55% by weightelastomer plasticizer, about 4% to about 35% by weight filler, about 5%to about 35% by weight softener, and optional minor amounts (about 1% orless by weight) of miscellaneous ingredients such as colorants,antioxidants, etc.

Synthetic elastomers may include, but are not limited to,polyisobutylene with GPC weight average molecular weight of about 10,000to about 95,000, isobutylene-isoprene copolymer (butyl elastomer),styrene-butadiene, copolymers having styrene-butadiene ratios of about1:3 to about 3:1, polyvinyl acetate having GPC weight average molecularweight of about 2,000 to about 90,000, polyisoprene, polyethylene, vinylacetate—vinyl laurate copolymer having vinyl laurate content of about 5%to about 50% by weight of the copolymer, and combinations thereof.

Preferred ranges for polyisobutylene are 50,000 to 80,000 GPC weightaverage molecular weight and for styrene-butadiene are 1:1 to 1:3 boundstyrene-butadiene, for polyvinyl acetate are 10,000 to 65,000 GBC weightaverage molecular weight with the higher molecular weight polyvinylacetates typically used in bubble gum base, and for vinyl acetate-vinyllaurate, vinyl laurate content of 10-45%.

Natural elastomers may include natural rubber such as smoked or liquidlatex and guayule as well as natural gums such as jelutong, lechi caspi,perillo, sorva, massaranduba balata, massaranduba chocolate, nispero,rosindinha, chicle, gutta hang kang, and combinations thereof. Thepreferred synthetic elastomer and natural elastomer concentrations varydepending on whether the chewing gum in which the base is used isadhesive or conventional, bubble gum or regular gum, as discussed below.Preferred natural elastomers include jelutong, chicle, sorva andmassaranduba balata.

Elastomer plasticizers may include, but are not limited to, naturalrosin esters such as glycerol esters or partially hydrogenated rosin,glycerol esters of polymerized rosin, glycerol esters of partiallydimerized rosin, glycerol esters of rosin, pentaerythritol esters ofpartially hydrogenated rosin, methyl and partially hydrogenated methylesters of rosin, pentaerythritol esters of rosin; synthetics such asterpene resins derived from alpha-pinene, beta-pinene, and/ord-limonene; and any suitable combinations of the foregoing. Thepreferred elastomer plasticizers will also vary depending on thespecific application, and on the type of elastomer which is used.

Fillers/texturizers may include magnesium and calcium carbonate, groundlimestone, silicate types such as magnesium and aluminum silicate, clay,alumina, talc, titanium oxide, mono-, di- and tri-calcium phosphate,cellulose polymers, such as wood, and combinations thereof.

Softeners/emulsifiers may include tallow, hydrogenated tallow,hydrogenated and partially hydrogenated vegetable oils, cocoa butter,glycerol monostearate, glycerol triacetate, lecithin, mono-, di- andtriglycerides, acetylated monoglycerides, fatty acids (e.g. stearic,palmitic, oleic and linoleic acids); and combinations thereof.

Colorants and whiteners may include FD&C-type dyes and lakes, fruit andvegetable extracts, titanium dioxide, and combinations thereof.

The base may or may not include wax. An example of a wax-free gum baseis disclosed in U.S. Pat. No. 5,286,500, the disclosure of which isincorporated herein by reference.

In addition to a water insoluble gum base portion, a typical chewing gumcomposition includes a water soluble bulk portion and one or moreflavoring agents. The water soluble portion can include bulk sweeteners,high-intensity sweeteners, flavoring agents, softeners, emulsifiers,colors, acidulants, fillers, antioxidants, and other components thatprovide desired attributes.

Softeners are added to the chewing gum in order to optimize thechewability and mouth feel of the gum. The softeners, which are alsoknown as plasticizers and plasticizing agents, generally constitutebetween approximately 0.5% to about 15% by weight of the chewing gum.The softeners may include glycerin, lecithin, and combinations thereof.Aqueous sweetener solutions such as those containing sorbitol,hydrogenated starch hydrolysates, corn syrup and combinations thereof,may also be used as softeners and binding agents in chewing gum.

Bulk sweeteners include both sugar and sugarless components. Bulksweeteners typically constitute about 5% to about 95% by weight of thechewing gum, more typically, about 20% to about 80% by weight, and morecommonly, about 30% to about 60% by weight of the gum. Sugar sweetenersgenerally include saccharide-containing components commonly known in thechewing gum art, including but not limited to, sucrose, dextrose,maltose, dextrin, dried invert sugar, fructose, levulose, glactose, cornsyrup solids, and the like, alone or in combination. Sugarlesssweeteners include, but are not limited to, sugar alcohols such assorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol,and the like, alone or in combination.

High-intensity artificial sweeteners can also be used, alone or incombination, with the above. Preferred sweeteners include, but are notlimited to, sucralose, aspartame, salts of acesulfame, altitame,saccharin and its salts, cyclamic acid and its salts, glycerrhizinate,dihydrochalcones, thaumatin, monellin, and the like, alone or incombination. In order to provide longer lasting sweetness and flavorperception, it may be desirable to encapsulate or otherwise control therelease of at least a portion of the artificial sweetener. Suchtechniques as wet granulation, wax granulation, spray drying, spraychilling, fluid bed coating, coacervation, and fiber extension may beused to achieve the desired release characteristics.

Combinations of sugar and/or sugarless sweeteners may be used in chewinggum. Additionally, the softener may also provide additional sweetnesssuch as with aqueous sugar or alditol solutions.

If a low calorie gum is desired, a low caloric bulking agent can beused. Examples of low caloric bulking agents include: polydextrose;Raftilose, Raftilin; Fructooligosaccharides (NutraFlora); Palatinoseoligosaccharide; Guar Gum Hydrolysate (Sun Fiber); or indigestibledextrin (Fibersol). However, other low calorie bulking agents can beused.

A variety of flavoring agents can also be used, if desired. The flavorcan be used in amounts of about 0.1 to about 15 weight percent of thegum, and preferably, about 0.2% to about 5% by weight. Flavoring agentsmay include essential oils, synthetic flavors or mixtures thereofincluding, but not limited to, oils derived from plants and fruits suchas citrus oils, fruit essences, peppermint oil, spearmint oil, othermint oils, clove oil, oil of wintergreen, anise and the like. Artificialflavoring agents and components may also be used. Natural and artificialflavoring agents may be combined in any sensorially acceptable fashion.

The gum center can be prepared using a variety of different methods andmachinery known in the art. For example, the formulation can be mixedusing a sigma blade mixer. The center formulation may also be made bycontinuous processing equipment known in the art. Conventional sheetingand scoring machinery can be used to form and score the centers or thecenters can be made on a forming machine that involves a drop frame andnitrogen cooling allowing spheres, ovals, and other shapes to be made.

By way of example, and not limitation, examples of some coated chewinggum formulations including a medicament or agent are as follows:

EXAMPLES

Examples of formulations follow.

Chewing Gum Center Formulation, percentage composition:

Example Example Example Example Example Ingredient 1 2 3 4 5 Sorbitol30.70 30.70 34.80 32.30 35.50 Base 44.00 46.00 41.00 44.00 38.00 Calcium10.00 9.00 10.50 10.00 11.00 Carbonate Maltitol 2.00 3.00 1.50 2.00 2.50Glycerin 1.50 5.00 3.50 4.00 4.50 70% Sorbitol 3.50 2.50 3.50 3.50 2.00Solution Flavor 6.00 2.50 2.50 2.50 3.00 Menthol 0.50 — — 0.50 1.00Granulated — 0.50 — 0.50 — Aspartame Encapsulated 0.10 0.10 — 0.50 0.50Aspartame Acesulfame 1.00 — 1.00 — 1.00 K Encapsulated 0.45 — 1.00 —0.30 Sucralose Citric Acid — 0.50 — — 0.40 Lecithin 0.25 0.20 0.20 0.200.30 Total 100.00 100.00 100.00 100.00 100.00 Percentage

Chewing gum ingredients may be mixed in a Sigma Blade Mixer or in acontinuous extruding mixer. After mixing, the gum mass is passed througha series of rollers ultimately ending with a pelletizing roller whichscored the gum into pieces of the desired mass. Those were manuallyreformed into disk shaped pieces. A preferred method would be a sheetingmethod, which would produce the desired disk shaped center withoutmanual manipulation.

Powder Coating Formulation, percentage composition:

Example Example Example Example Example Ingredient 6 7 8 9 10 Sorbitol70.90 — — 63.30 — Dextrose — 68.30 — — 60.00 Fructose — — 65.00 — —Encapsulated 15.00 — — 22.60 — Aceta- minophen Powder — 18.00 — — —Aceta- minophen Granular — — 20.00 — — Aceta- minophen Granulated — — —— 25.00 Aceta- minophen Polvinyl — 5.00 — — 6.50 pyrolidone Micro- 6.00— 5.50 6.00 — crystalline Cellulose Aspartame 3.00 2.40 2.00 2.40 5.00Sucralose 1.50 2.00 3.50 1.50 — WS-23 0.10 0.20 0.30 0.10 0.25 Calcium —1.00 — — 0.75 Stearate Magnesium 1.00 — 0.60 1.00 — Stearate Flavor 3.003.00 3.00 3.00 2.20 Color 0.10 0.10 0.10 0.10 0.30 Total 100.00 100.00100.00 100.00 100.00 Percentage

The powder formulations can then be placed around the chewing gumcenters to make a product. For example, a chewing gum as in Example 4was coated with Example 9, by using a calibrated volumetric scoop tomeasure 0.9 grams of powder and poured into the tablet die on a rotarytablet press. The gum center was manually placed on top of the powderand centered, and the volumetric scoop was used to deliver an additional0.9 gm of coating powder over the gum center. The rotary press wascycled through one full rotation to compress the powder around the gumcenter.

Experiment No. 1

The aforementioned Example 11 was compared to a pan coated product madein the following manner: Chewing gum ingredients may be mixed in a SigmaBlade Mixer or in a continuous extruding mixer. After mixing, the gummass is passed through a series of rollers ultimately ending with apelletizing roller which scored the gum into pieces of the desired shapeand size.

The gum centers were loaded into a conventional perforated pan andcoated in a manner typical of standard confections. The pellet bed wasdoused with syrup and allowed to tumble for a period of time todistribute the syrup and dried for another fixed period of time. Duringthe intermediate phases of this process, a dry charge consisting ofmaltitol and powdered acetaminophen was sprinkled on the moist bed ofpellets and incorporated into the pellet coating prior to completedrying. This is repeated as necessary to build up the desired drug doseon the outside of the pellets.

Kinetic analysis was performed on three subjects to determine the amountof acetaminophen, which was chewed into the cud. The comparativeexamples used were Driam pan coated gum with a 195 mg/pellet ofacetaminophen and Driam pan coated gum with 150 mg/pellet ofacetaminophen were compared to the experimental samples of CompressedTablet Chewing Gum with 355 mg/pellet of acetaminophen. The time pointstaken for the pan coated 195 mg/pellet product were at 0, 2, 5, 10 and20 minutes. Time points for the 150 mg/pellet product were at 0, 10, 20,30, and 40 minutes. The time points taken for the Compressed TabletChewing Gum 355 mg/pellet product were 0, 1, 3, 5, 8, 14, and 20minutes.

FIG. 2 illustrates graphically the results of this analysis.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its intended advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

What is claimed is:
 1. A chewing gum product including a medicamentcomprising: a chewing gum center; and a compressible compositioncomprising an encapsulated medicament that is compressed around thechewing gum center.
 2. The chewing gum product of claim 1 wherein theproduct has a disk shape.
 3. The chewing gum product of claim 1 whereinthe product has a pellet shape.
 4. The chewing gum product of claim 1wherein the product has a spherical shape.
 5. The chewing gum product ofclaim 1 wherein the product has a cube shape.
 6. The chewing gum productof claim 1 wherein the encapsulated medicament is encapsulated with acomposition selected from the group consisting of: natural polymers;synthetic polymers; modified cellulosics; waxes; fats; oils; andprotein.
 7. The chewing gum product of claim 1 wherein the chewing gumcenter has the same shape as the product.
 8. The chewing gum product ofclaim 1 wherein the medicament is selected from the group consisting of:analgesics; muscle relaxants; antacids; antihistamines; decongestants;anti-inflammatories; oral vaccines; probiotics; antibiotics;anti-virals; cancer chemotherapies; antimycotics; oral contraceptives;diuretics; antitussives; anesthetics; bioengineered pharmaceuticals;psycotherapeutic agents; hormones; cardiovascular agents; vitamins;insulin; minerals; and nutraceuticals.
 9. The chewing gum product ofclaim 1 wherein the compressible composition includes a masking agent.10. A composition including a medicament comprising: a chewing gumcenter; and a compressible formulation including a medicament thatsurrounds the entire chewing gum center.
 11. The composition of claim 10wherein the medicament is encapsulated.
 12. The composition of claim 10wherein the chewing gum composition has a disk shape.
 13. Thecomposition of claim 10 wherein the medicament is encapsulated with acomposition selected from the group consisting of: natural polymers;synthetic polymers; modified cellulosics; waxes; fats; oils; andprotein.
 14. The composition of claim 10 wherein the medicament isselected from the group consisting of: analgesics; muscle relaxants;antacids; antihistamines; decongestants; anti-inflammatories;antibiotics; anti-virals; oral vaccines; probiotics; psycotherapeuticagents; hormones; cardiovascular agents; vitamins; minerals; insulin;and nutraceuticals.
 15. An acetominophen containing product comprising:a chewing gum center; and a compressible composition includingencapsulated acetaminophen that is compressed around the chewing gumcenter.
 16. The acetominophen containing product of claim 15 wherein theproduct has a disk shape.
 17. The acetominophen containing product ofclaim 15 wherein the acetominophen is encapsulated with a compositionselected from the group consisting of: natural polymers; syntheticpolymers; modified cellulosics; waxes; fats; oils; and protein.
 18. Theacetominophen containing product of claim 15 wherein the chewing gumcenter has the same shape as the product.
 19. A method of delivering amedicament comprising the steps of: providing a chewing gum center;compressing around the chewing gum center a composition including amedicament to produce a product; and causing an individual in need ofthe medicament to chew the product.
 20. The method of claim 19 whereinthe medicament is encapsulated.
 21. The method of claim 20 wherein themedicament is encapsulated with a composition selected from the groupconsisting of: natural polymers; synthetic polymers; modifiedcellulosics; and protein.
 22. The method of claim 19 wherein the productis chewed a plurality of times per day.
 23. The method of claim 19wherein the medicament is selected from the group consisting of:analgesics; muscle relaxants; antacids; antihistamines; decongestants;anti-inflammatories; antibiotics; anti-virals; oral vaccines;probiotics; cancer chemotherapies; antimycotics; oral contraceptives;diuretics; antitussives; anesthetics; bioengineered pharmaceuticals;insulin; psycotherapeutic agents; hormones; cardiovascular agents;vitamins; minerals; and nutraceuticals.
 24. The method of claim 19wherein the medicament is acetominophen.
 25. A method for providing amedicament comprising the steps of: providing a chewing gum center; andcompressing around the chewing gum center a composition including amedicament.
 26. The method of claim 25 wherein the medicament isencapsulated with a composition selected from the group consisting of:natural polymers; synthetic polymers; modified cellulosics; waxes; fats;oils; and protein.
 27. The method of claim 25 wherein the medicament isselected from the group consisting of: analgesics; muscle relaxants;antacids; antihistamines; decongestants; anti-inflammatories;antibiotics; anti-virals; cancer chemotherapies; antimycotics; oralcontraceptives; diuretics; antitussives; anesthetics; oral vaccines;probiotics; bioengineered pharmaceuticals; insulin; psycotherapeuticagents; hormones; cardiovascular agents; vitamins; minerals; andnutraceuticals.
 28. The method of claims 25 wherein the medicament isacetominophen.
 29. A method of producing a medicament containing productcomprising the steps of: producing a chewing gum center; and surroundingthe chewing gum center with a compressible powder that includes amedicament.
 30. The method of claim 29 wherein the medicament isencapsulated with a composition selected from the group consisting of:natural polymers; synthetic polymers; modified cellulosics; and protein.31. The method of claim 29 wherein the medicament is selected from thegroup consisting of: analgesics; muscle relaxants; antacids;antihistamines; decongestants; anti-inflammatories; antibiotics;anti-virals; cancer chemotherapies; antimycotics; oral contraceptives;diuretics; antitussives; anesthetics; bioengineered pharmaceuticals;psycotherapeutic agents; hormones; cardiovascular agents; oral vaccines;probiotics; insulin; vitamins; minerals; and nutraceuticals.
 32. Themethod of claim 29 including the step of compressing the powder aroundthe chewing gum center.